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Atossa Therapeutics Announces New Regulatory Strategy

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Atossa Therapeutics Announces New Regulatory Strategy

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Atossa Therapeutics ( (ATOS) ) just unveiled an update.

On September 8, 2025, Atossa Therapeutics announced a new regulatory strategy to accelerate the development of low-dose (Z)-endoxifen for breast cancer risk reduction. The company has requested a Type C meeting with the FDA to discuss this strategy, which could potentially shorten approval timelines and reduce clinical trial costs significantly. Atossa’s (Z)-endoxifen offers a promising alternative to tamoxifen, with a more predictable and faster-acting therapy, addressing the unmet needs in breast cancer risk-reduction settings. The company is also advancing its Phase 2 Project Optimus trial to identify the optimal dose in metastatic breast cancer, which supports the development in the risk-reduction setting.

The most recent analyst rating on (ATOS) stock is a Buy with a $7.00 price target. To see the full list of analyst forecasts on Atossa Therapeutics stock, see the ATOS Stock Forecast page.

Spark’s Take on ATOS Stock

According to Spark, TipRanks’ AI Analyst, ATOS is a Underperform.

Atossa Therapeutics’ stock score is weighed down by significant financial challenges, including ongoing operational losses and negative cash flow, despite a debt-free balance sheet. Technical indicators suggest short-term overbought conditions, while the valuation remains unattractive due to a lack of profitability and dividends. Although the earnings call provided some positive guidance on cost reductions and clinical progress, these are overshadowed by the company’s financial instability.

To see Spark’s full report on ATOS stock, click here.

More about Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment through innovative science and patient-focused solutions. The company’s lead product candidate, (Z)-endoxifen, is a highly potent selective estrogen receptor modulator/degrader designed for use across the breast cancer spectrum, including risk-reduction and treatment in various settings.

Average Trading Volume: 1,113,117

Technical Sentiment Signal: Strong Sell

Current Market Cap: $101.8M

Find detailed analytics on ATOS stock on TipRanks’ Stock Analysis page.

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